FDA.reportPublic FDA data

MAUDE MDR 4652354

MDR report key
4652354
Report number
MW5041803
Event key
0
Event type
3
Date received
2015-03-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NASALCARE NASALCLEANSE KITNASALCARE NASALCLEANSE KITTECHWORLD CORPORATION, INCKMA8355120

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-2801. L

Event Narratives#

D

Patient 1

WE PURCHASED A NASALCARE NASALCLEANSE KIT ONLINE. THEN WE FOUND THERE ARE SOME SMALL PARTS COULD BE DANGER TO OUR LITTLE KIDS. THEN WE TRIED TO CALL THE TOLL FREE # ON THE PACKAGE 1888-658-8108. THERE WAS NO ONE ANSWER THE PHONE BUT ASKED US TO GOT TO (B)(6). BUT THE PRODUCT WAS MANUFACTURED BY (B)(6). WE CHECKED (B)(6) STATE WEBSITE, THERE IS NO SUCH AS TECHWORLD MEDICALS, INC (B)(6)! WE DON'T KNOW WHAT IS GOING ON HERE.